The following data is part of a premarket notification filed by Cunningham Woodland, Inc. with the FDA for Venous Cannula Tray.
Device ID | K813284 |
510k Number | K813284 |
Device Name: | VENOUS CANNULA TRAY |
Classification | Instruments, Surgical, Cardiovascular |
Applicant | CUNNINGHAM WOODLAND, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWS |
CFR Regulation Number | 870.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-23 |
Decision Date | 1981-12-29 |